Congestive Heart FailureNCT05540158
A Mobile Integrated Health Intervention to Manage Congestive Health Failure and Chronic Obstructive Pulmonary Disease
An observational study of Congestive Heart Failure and Copd, run by University of Massachusetts, Worcester.
Trial summary
Episodic and disjointed medical care for older, community-dwelling adults with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) leave them vulnerable to adverse events such as worsening disease trajectories, frequent emergency department (ED) utilization, and avoidable hospital… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Congestive Heart Failure, Copd
- What is being tested?
- Mobile Integrated Health Intervention
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2025to Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community dwelling adults in Worcester county Massachusetts who are members of the Umass Memorial accountable care organization who have a diagnosis of chronic obstructive pulmonary disease or congestive heart failure
Who may be able to join
- Community Dwelling
- Residing in the catchment area of Worcester and Shrewsbury Massachusetts
- member of the UMMHC accountable care organization for at least one year prior to the implementation of the intervention
- Carry a diagnosis of congestive heart failure or chronic obstructive pulmonary disease
- Adult over eighteen
- Fluent in English
- Able to participate in a verbal interview either in-person or via zoom video conference
- Able to provide informed consent to participate in the study
Who cannot join
- Adults unable to consent
- Non-English-speaking adults
- Prisoners
- Patients under age 18 years
- Trainees, including medical students, resident physicians, and fellows will be excluded from this study.
About this study
Official title: A Mobile Integrated Health Intervention for the Management of Acute-phase Exacerbation of Congestive Health Failure and Chronic Obstructive Pulmonary Disease
Episodic and disjointed medical care for older, community-dwelling adults with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) leave them vulnerable to adverse events such as worsening disease trajectories, frequent emergency department (ED) utilization, and avoidable hospital admissions. It is imperative that an alternative means of health delivery be developed, establishing a coordinated, flexible care model to connect patients with the appropriate resources to address their acute needs and integrate with their medical homes to navigate fraught moments in their disease management.
The Mobile integrated health (MIH) care delivery model may offer a solution by providing flexible and innovative on-demand care in the comfort of patients' homes. The MIH paradigm expands the use of highly trained paramedics outside of their traditional EMS role, by dispatching them into the community to perform in-home medical evaluations and treatment(s) in consultation with an actively involved, remotely located, supervising physician. These "community paramedics" evaluate patients and render care using mobile diagnostics and a variety of medications, allowing patients to remain in place until they can be evaluated definitively on an ambulatory basis.
Read more
Utilizing a model of on-demand community paramedic visits paired with a telehealth consultation with a physician, this intervention will manage patients in place until they can access planned ambulatory follow up, decreasing the use of prehospital emergency transport services, emergency department utilizations, and hospital admissions as well as limiting transitions of care and allowing ambulatory providers to maintain longitudinal oversight of disease management
The objective of this project is to study the feasibility of the refined MIH model for the care of community dwelling patients with congestive heart failure and chronic obstructive pulmonary disease. Investigators will conduct a small pre/post pilot intervention trial enrolling 50 patients into a pilot MIH program. Primary outcomes will include participant satisfaction, patient activation, and subject retention. Investigators will also collect outcomes data including ED visits, hospitalizations, and hospital lengths of stay.
- Conditions
- Congestive Heart Failure, Copd
- Being tested
- Mobile Integrated Health Intervention
- Keywords
- Allied Health Personnel, Mobile Health Units, Delivery of Health Care, Integrated
- Medical subject headings
- Heart Failure, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Integrated Health InterventionOther
Subjects will have access to "on-demand" mobile integrated health program for acute symptoms. Subjects will be educated on the nature and capabilities of the MIH community paramedics and will be able to call a hotline for unscheduled visits 24 hours a day, 7 days a week if they wish to be evaluated for acute symptoms or changes in their condition. All visits entail focused history and physical exam with community paramedic, portable diagnostics as indicated, and telehealth visit with a physician
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject retention in study
The number of subjects who participate in study for entire 1 year duration
Measured: 1 year after initial recruitment
Subject reported acceptability of the MIH program
Subjects will self report their satisfaction and utilization history with MIH program using 5 point Likert scales (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree) evaluating their experiences with the MIH service. A high score indicates greater satisfaction
Measured: baseline, 6 months and 1 year after initial recruitment
Patient activation measure
Measure of a subject's knowledge, skills and confidence to manage their own health and well-being. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient activation.
Measured: baseline, 6 months and 1 year after initial recruitment
Brief Illness Perception Questionnaire
Measures subject's self-reported perception of their chronic illness through several statements that patients agree with on a 1-10 scale, with 10 being most strongly agree.
Measured: baseline, 6 months and 1 year after initial recruitment
Patient satisfaction questionnaire
Measures subject's self-reported satisfaction with their health care. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient satisfaction.
Measured: baseline, 6 months and 1 year after initial recruitment
Secondary outcomes (1)
Healthcare Utilizations
number of MIH, ambulatory, and emergency services utilizations
Measured: 1 year prior to, and 6 months and 1 year after initial recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study startJan 2025 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Why it stopped: The study design underwent substantial modifications, including changes to the population, intervention, and primary outcomes. As a result, a new trial was registered under a separate ClinicalTrials.gov identifier (NCT06000696).
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congestive Heart FailureStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laurel O'Connor, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540158
- Sponsor's protocol ID
- STUDY00000126
- Status last verified
- Mar 2025
- First submitted
- 10 Sep 2022
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mobile Integrated Health Intervention for the Management of Acute-phase Exacerbation of Congestive Health Failure and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05540158
- Acronym / sponsor ID
- STUDY00000126
- Conditions
- Congestive Heart Failure, Copd
- Keywords
- Allied Health Personnel, Mobile Health Units, Delivery of Health Care, Integrated
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: The study design underwent substantial modifications, including changes to the population, intervention, and primary outcomes. As a result, a new trial was registered under a separate ClinicalTrials.gov identifier (NCT06000696).
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Study start
- Jan 2025 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Episodic and disjointed medical care for older, community-dwelling adults with chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF) leave them vulnerable to adverse events such as worsening disease trajectories, frequent emergency department (ED) utilization, and avoidable hospital admissions. It is imperative that an alternative means of health delivery be developed, establishing a coordinated, flexible care model to connect patients with the appropriate resources to address their acute needs and integrate with their medical homes to navigate fraught moments in their disease management.
The Mobile integrated health (MIH) care delivery model may offer a solution by providing flexible and innovative on-demand care in the comfort of patients' homes. The MIH paradigm expands the use of highly trained paramedics outside of their traditional EMS role, by dispatching them into the community to perform in-home medical evaluations and treatment(s) in consultation with an actively involved, remotely located, supervising physician. These "community paramedics" evaluate patients and render care using mobile diagnostics and a variety of medications, allowing patients to remain in place until they can be evaluated definitively on an ambulatory basis.
Utilizing a model of on-demand community paramedic visits paired with a telehealth consultation with a physician, this intervention will manage patients in place until they can access planned ambulatory follow up, decreasing the use of prehospital emergency transport services, emergency department utilizations, and hospital admissions as well as limiting transitions of care and allowing ambulatory providers to maintain longitudinal oversight of disease management
The objective of this project is to study the feasibility of the refined MIH model for the care of community dwelling patients with congestive heart failure and chronic obstructive pulmonary disease. Investigators will conduct a small pre/post pilot intervention trial enrolling 50 patients into a pilot MIH program. Primary outcomes will include participant satisfaction, patient activation, and subject retention. Investigators will also collect outcomes data including ED visits, hospitalizations, and hospital lengths of stay.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community dwelling adults in Worcester county Massachusetts who are members of the Umass Memorial accountable care organization who have a diagnosis of chronic obstructive pulmonary disease or congestive heart failure
Key inclusion criteria (8 listed)
- Community Dwelling
- Residing in the catchment area of Worcester and Shrewsbury Massachusetts
- member of the UMMHC accountable care organization for at least one year prior to the implementation of the intervention
- Carry a diagnosis of congestive heart failure or chronic obstructive pulmonary disease
- Adult over eighteen
Key exclusion criteria (5 listed)
- Adults unable to consent
- Non-English-speaking adults
- Prisoners
- Patients under age 18 years
- Trainees, including medical students, resident physicians, and fellows will be excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Integrated Health InterventionSubjects will have access to "on-demand" mobile integrated health program for acute symptoms. Subjects will be educated on the nature and capabilities of the MIH community paramedics and will be able to call a hotline for unscheduled visits 24 hours a day, 7 days a week if they wish to be evaluated for acute symptoms or changes in their condition. All visits entail focused history and physical exam with community paramedic, portable diagnostics as indicated, and telehealth visit with a physician | Other | – |
Primary outcome
Subject retention in study
Time frame: 1 year after initial recruitment
The number of subjects who participate in study for entire 1 year duration
Subject reported acceptability of the MIH program
Time frame: baseline, 6 months and 1 year after initial recruitment
Subjects will self report their satisfaction and utilization history with MIH program using 5 point Likert scales (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree) evaluating their experiences with the MIH service. A high score indicates greater satisfaction
Patient activation measure
Time frame: baseline, 6 months and 1 year after initial recruitment
Measure of a subject's knowledge, skills and confidence to manage their own health and well-being. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient activation.
Brief Illness Perception Questionnaire
Time frame: baseline, 6 months and 1 year after initial recruitment
Measures subject's self-reported perception of their chronic illness through several statements that patients agree with on a 1-10 scale, with 10 being most strongly agree.
Patient satisfaction questionnaire
Time frame: baseline, 6 months and 1 year after initial recruitment
Measures subject's self-reported satisfaction with their health care. Questions are answered on the following scale: (5-Strongly Agree, 4-Agree, 3-Neutral, 2-Disagree, 1-Strongly Disagree). A higher score indicates greater patient satisfaction.
1 secondary outcome
Healthcare Utilizations
Time frame: 1 year prior to, and 6 months and 1 year after initial recruitment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Congestive Heart Failure and Copd, run by University of Massachusetts, Worcester.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 20 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject retention in study (time frame: 1 year after initial recruitment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2025.